Genetically Engineered Foods: Fears and Facts

by Food and Drug Administration (FDA)

Genetic engineering of fruits and vegetables and FDA's policy concerning these foods have been the subject of many consumer questions recently. To help answer the questions, FDA Consumer writer Mary Alice Sudduth talked to James Maryanski, biotechnology coordinator in FDA's Center for Food Safety and Applied Nutrition.

Q: What is "new biotechnology" in reference to food plants, and how does it differ from old biotechnology?

A: All plant breeding involves genetic manipulation of plants. There are hundreds of new plant varieties introduced every year in the United States, and all have been genetically modified through traditional plant breeding techniques — such as cross-fertilization of selected plants — to produce desired traits. This is "old biotechnology." The new biotechnology — known variously as gene splicing, recombinant DNA, or genetic engineering — is actually an extension of traditional plant breeding. It involves direct modification of DNA, a living thing's genetic material. This new technique is more precise, making it possible to direct and predict changes without introducing extraneous, undesirable traits. The new technique also will allow scientists to introduce genes from essentially any organism into a plant.

Q: Why do we need these plants and the foods they produce?

A: Plant breeders have a limited pool of genes — and, therefore, traits — available for use in improving plants. By looking at bacteria and animals, scientists can find other traits that may expand the number of potentially useful traits. These may include size, solids content, or resistance to certain viruses or fungi.

Q: Under what circumstances will FDA require labeling of genetically engineered foods?

A: One important area is that of potential allergens. If a gene from a food that commonly causes allergic reactions, like fish or peanuts, is inserted into tomatoes or corn, where people would not expect to find allergens, then the vegetables would have to be labeled to alert sensitive consumers. If companies can demonstrate scientifically that the allergenic component was not transferred to the vegetable, no special label will be required. FDA's policy states that proteins taken from commonly allergenic foods are presumed to be allergens unless demonstrated otherwise. Labeling also could be required if the nutritional content of the food is changed. Tomatoes are a major source of vitamin C, and if someone develops a tomato that no longer contains vitamin C, then that will have to be disclosed. So we envision a number of circumstances where labeling will be necessary, and we'll use the same labeling regulations we've always used under the FD&C Act. We've invited public comment on this issue, because we anticipate consumers will have diverse opinions about genetic engineering and about what information should appear on labels.

Q: FDA has emphasized the importance of proper labeling of foods and has initiated legal action against certain products — Citrus Hill "fresh" orange juice, for example — because of misleading labeling. How does this differ from labeling biotechnology-derived foods? Isn't the fundamental issue the same — full disclosure?

A: The law says labeling for foods must disclose information that's material, as well as avoid false or misleading statements. It's our view that the method by which a plant is developed by a plant breeder is not material information in the sense of the law. For example, we do not require sweet corn to be labeled "hybrid sweet corn" because it was developed through cross-hybridization. And plant breeders have many other traditional techniques through which they coax nature to change genes that would not occur otherwise. A process called somoclonal variation allows breeders to take advantage of natural mutations in plant cells that produce desired traits. Through embryo rescue, breeders nurture embryos produced by crossing two plant varieties that would not breed naturally, producing potentially useful plants that would not have survived on their own. Historically, we have not required this information to be on labels. It would not be practical. If genetic engineering or any other technique changes the composition of a tomato in a way that it's really not the same tomato anymore, then it would have to be called something different. It would have to have a different varietal name, or, if it was a significant difference, it may not even be called a tomato. We are reviewing the comments from the public on this issue to see if there is a basis for modifying our policy. However, if we were to require labeling of all genetically engineered fruits and vegetables, it would not be merely a matter of putting a sticker on a tomato or a banana. Producers would have to segregate the genetically engineered foods from other varieties, whereas normally those are all just lumped into a barrel. And then what happens when you make tomato paste, and that tomato paste is used to make pizzas? Does the label have to follow along through the food processing chain? It would increase the cost of these foods to consumers and would disrupt our complex food distribution system.

Q: Are there environmental risks involved in producing genetically altered foods?

A: Potential environmental risks from these crops are the same as those that occur in plants developed by traditional methods. There are many complex issues — such as potential transfer of traits to other plants and potential adverse effects on other organisms, particularly endangered species — that need to be taken into account. For example, if a plant has many wild relatives, it could pass a gene to one of those, resulting in an outcross plant species with some undesirable traits. The wild plants could develop into a fast-growing weed species, for instance. For some crops, like tomatoes, this really isn't a risk in the United States because there are few, if any, wild relatives of tomatoes that could be bred accidentally. But there are other plants, such as soybeans and squash, where there will be potential for an outcross species. Whether outcrossing is a problem depends on the trait that's introduced, as well. Environmental risks are looked at during the research and development phase. Right now, crops developed using recombinant DNA methods are reviewed by the U.S. Department of Agriculture's Animal and Plant Health Inspection Service. If FDA acts on a food additive petition or GRAS [generally recognized as safe] petition for a new ingredient, we will do an environmental assessment. We will look at what the other agencies have done, and, to the extent possible, we will rely on their information. If there are other issues, they will have to be considered.

Q: How can consumers be sure companies producing these foods will test them adequately and take all necessary measures to ensure they are safe for consumption and will not harm the environment?

A: All the companies that we've talked to are doing the kinds of tests that we would think need to be done. In May, FDA published a notice in the Federal Register providing a guide for companies that establishes a standard of care. What's happening now is that companies are coming to us and telling us the kinds of tests they're proposing based on the guidance in our Federal Register notice. And they're asking for our advice.

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